NCT03216915

Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis

FINGORHYMS - Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The current study sought to prolong the observational interval after initiating medication with fingolimod and to measure the long-term effects of fingolimod on HR and HRV as an indicator of autonomic nervous system function in patients with RR-MS.

Detailed description

Fingolimod (Gilenya®; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA) is a novel oral disease-modifying therapy that acts as a sphingosine-1-phosphate (S1P) receptor agonist and reduces the recirculation of lymphocytes to blood and peripheral tissues, including inflammatory lesions. A critical part of fingolimod therapy still remains in the screening and initiation phases because of the risk of cardiac events. It is well known that the first dose of fingolimod is associated with a decrease in heart rate (HR) and slowing of atrioventricular (AV) conduction. Patients were continuously observed for a minimum of 6 hours after taking fingolimod. Because resurgence of heart rate began at 6 hours, the actual recommendation for observation is only 6 hours. Data about the effect of fingolimod after this time period is lacking.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Gilenya®; Novartis Pharmaceuticals Corporation	This is a prospective cohort-based study. Eligible are all patients planned for a treatment with fingolimod at the Hamburg University Hospital who are willing and able to participate in an observational study.

Timeline

• Start date: 2013-06-01
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2017-07-13
• Last updated: 2019-01-08

Locations

1 site across 1 country: Germany